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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K940684
Device Name SURGICAL INSTRUMENT, DISPOSABLE
Applicant
Her-Mar, Inc.
P.O. Box 402916
Miami Beach,  FL  33140
Applicant Contact RONALD MAYER
Correspondent
Her-Mar, Inc.
P.O. Box 402916
Miami Beach,  FL  33140
Correspondent Contact RONALD MAYER
Regulation Number878.4800
Classification Product Code
MDM  
Date Received02/10/1994
Decision Date 03/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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